Overview
Sponsor-declared trial summary
Acute non-complicated appendicitis in patients aged 7 to 18
To perform a complex clinical and economical study in children with acute appendicitis, provide new criteria for early diagnosis of acute noncomplicated appendicitis and its conservative treatment, as well as evaluate cost-efficiency.
Key facts
- Sponsor
- Riga Stradins University
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520496-19-00
- EudraCT number
- 2021-001729-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Diagnosis, Safety
To perform a complex clinical and economical study in children with
acute appendicitis, provide new criteria for early diagnosis of acute noncomplicated appendicitis and its conservative treatment, as well as
evaluate cost-efficiency.
Conditions and MedDRA coding
Acute non-complicated appendicitis in patients aged 7 to 18
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age: 7-18 years Dg. Primary acute non-complicated appendicitis ALVORADO score ≥ 7 Pain in right lower quadrant of abdomen Blood tests: C-reactive protein ≤ 10 mg/L *If performed: *Il-6 ≤ 39,2 pg/mL *Ultrasound - acute appendicitis signs
Exclusion criteria 1
- Positive pregnancy test Diffuse peritonitis Previous abdominal surgery Use of antibiotic drugs in previous 7 days Inflammatory bowel disease Immunosuppresive condition
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 3 days in-patient treatment; 7 days out-patient treatment
Secondary endpoints 1
- 1 month follow-up; 1 year follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Ceftazidime Fresenius Kabi 1000 mg pulveris injekciju šķīduma pagatavošanai
PRD11854779 · Product
- Active substance
- Ceftazidime Pentahydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD02 — -
- Marketing authorisation
- 08-0388
- MA holder
- FRESENIUS KABI POLSKA SP. Z O.O.
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pamecil 1 g pulveris injekciju/infūziju šķīduma pagatavošanai
PRD11831546 · Product
- Active substance
- Ampicillin
- Substance synonyms
- AMINOBENZYLPENICILLIN
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8000 mg milligram(s)
- Max total dose
- 24000 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- 98-0048
- MA holder
- MEDOCHEMIE LTD.
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoksiklav 875 mg/125 mg apvalkotās tabletes
PRD783099 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 14000 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 99-0267
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Medoclav 500 mg/125 mg apvalkotās tabletes
PRD11805741 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1250 mg milligram(s)
- Max total dose
- 8750 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 02-0324
- MA holder
- MEDOCHEMIE LTD.
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Metronidazole Unifarma 5 mg/ml škidums infuzijam
PRD9281426 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 4500 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XD01 — METRONIDAZOLE
- Marketing authorisation
- 05-0168
- MA holder
- UNIFARMA
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Riga Stradins University
- Sponsor organisation
- Riga Stradins University
- Address
- Dzirciema Iela 16
- City
- Riga
- Postcode
- 1007
- Country
- Latvia
Scientific contact point
- Organisation
- Riga Stradins University
- Contact name
- Timurs Zurmutaī
Public contact point
- Organisation
- Riga Stradins University
- Contact name
- Timurs Zurmutaī
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | TZ_protokols | 1 |
| Recruitment arrangements (for publication) | Not applicable for transition trials | 1 |
| Subject information and informed consent form (for publication) | Pacienta informeta piekrisana_LV_Timurs_Zurmutai1 | 1 |
| Subject information and informed consent form (for publication) | Pacienta informeta piekrisana_RU_Timurs_Zurmutai | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 1994112197e_19-12-2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 1995099208_10-08-2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2002040101_16-03-2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2004092336_22-12-2022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2008010059_18-07-2024 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Latvia | Acceptable 2025-01-30
|
2025-01-30 |